divendres, 31 de març del 2017

Bio2 Medical raises $1.5m, looking for $6.5m more

Bio2 Medical

Bio2 Medical raised $1.5 million in a new round of debt and option financing, according to an SEC filing posted this week.

Money in the round came from 1 unnamed investor, with the date of the sale noted as March 18, according to the filing. The company has not yet stated how it plans to spend funds raised during the offering.

Bio2 is looking to raise an additional $6.5 million before closing the round. A portion of the proceeds from the round will be used to pay the salaries of certain company officers, according to the filing.

Last August, Bio2 Medical pulled in $3 million from a 2nd tranche of financing from Oxford Finance after winning FDA 510(k) clearance for its Angel catheter.

The Angel catheter is designed to provide access to the central venous system and to trap blood clots before they can reach the lungs, according to the Golden, Colo.-based company. The FDA cleared the device July 28, 2016, Bio2 said last August.

Bio2 said it plans to use the funds to commercialize the Angel device in the U.S. by hiring sales reps, building up inventory and working on market development. The tranche is part of an $8 million secured term loan announced early this year which followed close on the heels of a $9 million Series D round last January.

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Pavmed files for $23m private placement

PAVmedPavmed (NSDQ:PAVMU) registered for an upcoming private placement, looking to raise approximately $23.4 million, according to an SEC filing posted this week.

The New York-based company will look to float approximately 1.4 million shares of Series A convertible preferred stock at $5.95 per share and 2.5 million Series X warrants to purchase additional shares at $5.95 per share, according to the SEC filing.

In February, Pavmed said it raised $1.5 million through a private placement of Series A convertible preferred stock and Series A warrants, with funds slated to support FDA clearance of its 1st product, the PortIO intraosseous infusion system.

The company said it is hopeful for for FDA 510(k) clearance for the PortIO by the end of the 2nd quarter of 2017. PAVmed said it also plans to file a 510(k) premarket notification submission for its 2nd product, the CarpX percutaneous system for the treatment of Carpal Tunnel Syndrome, during the 2nd quarter.

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7 medtech stories we missed this week: March 31, 2017

[Image from unsplash.com]

This week we saw a few FDA 510(k) clearances and one of the 1st uses of a next-generation surgical robot in Asia.

Here are 7 medtech stories we missed this week but thought were still worth mentioning:

1. Corindus touts first Asian use of next-generation robot

Corindus Vascular Robotics announced in a March 31 press release that robot-assisted PCI procedures were performed for the first time in Asia using the CorPath GRX system. The procedures were performed at Fu Wai Hospital. This is the first time the system has been used outside of the U.S. CorPath GRX enhances the precision and workflow of the current CorPath system and extends the capabilities and procedures that can be robot-assisted.

2. Endologix launches stent graft study

Endologix has announced that the first patients of its Expanding Patient Applicability with Polymer Sealing Ovation Alto Stent Graft (ELEVATE) IDE clinical study have been treated, according to a March 31 press release. The purpose of the clinical trial is to test the efficiency and safety of the Ovation alto abdominal stent graft system that repairs infrarenal abdominal aortic aneurysms. The clinical trials will have 75 participants across 12 centers in the U.S.

3. NeoSurgical inks Europe distribution deal for Neoclose

NeoSurgical announced in a March 29 press release that it has signed a distribution deal with a global partner to commercialize the Neoclose in Europe. Neoclose helps surgeons close port site defects up to 3 cm after laparoscopic abdominal surgery. It uses bioabsorbable anchors and a Vector-X closure to help change port site closure.

4. Bodycad gets FDA 510(k) clearance for unicompartmental knee system

Bodycad has received FDA 510(k) clearance for its personalized Unicompartmental Knee System, according to a March 29 press release. Bodycad says it is the first Canadian company to receive FDA clearance for a joint reconstruction implant system. The Unicompartmental Knee System is designed to optimize personalized knee restoration of a patient’s unique anatomical features and kinetics. It uses 3D rendering of medical images of the patient’s anatomy.

5. Providence Medical announces 510(k) clearance and new executive management team

Providence Medical Technology received FDA 510(k) clearance for its cervical fusion device and gained two new leaders on its commercial leadership team, according to a March 29 press release. Scott Lynch is the new lead of global marketing while Michael Scott is assuming international leadership. Provience also received 510(k) clearance for its standalone use of the Cavux Cervical Cage-L system and received approval for its Ally facet screws. The Cavux Cervical Cage-L system is made of medical grade titanium and available in a variety of sizes. The Ally facet screws give stabilization as an adjunct to spinal fusion.

6. TissueTech touts Amniox study

TissueTech announced the results of its Amniox Clarix Flo for plantar fasciitis study in a March 30 press release. The study showed the benefits of the application of Amniox’s cryopreserved human umbilical cord tissue for the treatment of patients with plantar fasciitis. The study included 43 patients who received Clarix Flo injections and were monitored for 18 weeks. The results showed that pain was significantly decreased from the baseline and there was an overall functionality recovery.

7. NeoTract touts 5-year pivotal data for UroLift prostate device

NeoTract announced its 5-year follow-up data from its randomized Lift IDE study that evaluated the safety and effectiveness of the company’s UroLift system, according to a March 27 press release. The system was tested in patients who have symptomatic benign prostatic hyperplasia and showed that the treatment provided a highly tolerable, minimally invasive procedural experience; rapid reduction of symptoms after the procedure while preserving sexual function and a higher quality of life.

Here’s what we missed last week.

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Align Technology, ClearCorrect trade blows in patent spat

Align, ClearCorrectClearCorrect and Align Technology (NSDQ:ALGN) both claimed victories in ongoing patent spats between the 2 related to transparent dental aligners this week.

Align Technology said on Tuesday that the US Patent and Trademark Office confirmed the validity of 2 patents which were being challenged by ClearCorrect. The company touted that the 2 confirmed patents are in addition to 3 patents which were issued reexamination certificates from the USPTO in February.

ClearCorrect claimed its own victory in a separate inter partes review of Align’s patents by the Patent Trial and Appeal Board. The PTAB ruled that several claims on the patent in question were invalid, while others remained intact.

San Jose, Calif.-based Align Technology said it believes that “the PTAB erred in its decision” and that it plans to appeal to the Court of Appeals for the Federal Circuit.

“We are pleased that, after reviewing four of the nine patents asserted against ClearCorrect in the Southern District of Texas infringement action, the Patent and Trademark Office has now issued reexamination certificates confirming that all the claims of those four asserted patents are valid and enforceable. While the PTAB’s ruling regarding the ‘037 patent is disappointing, it is important to note that Align is not asserting the ‘037 patent against ClearCorrect in the Southern District of Texas infringement litigation, or in any other current patent litigation, and we do not expect this decision to impact our infringement case against ClearCorrect,” Align Technology VP & GC Roger George said in a press release.

In February, Align it filed a patent infringement suit against ClearCorrect and Your Smile Direct in the UK, claiming the companies infringe upon patents related to its transparent dental aligners.

In the suit, Align Technology asserts that ClearCorrect infringes on 4 Align patents by marketing, importing and selling ClearCorrect’s clear aligners. The suit also includes 3 infringement charges against Your Smile Direct for marketing, importing and selling ClearCorrect aligners under the separate brand.

 

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AliveCor raises $30m

AliveCor has raised $30.1 million in a new round of equity financing, according to an SEC filing posted this week.

The Mountain View, Calif.-based company produces the Kardia mobile platform, which includes smartphone apps and accessories to allow for the monitoring of multiple vital signals.

AliveCor’s monitoring app can record 5 vital statistics, the company said, including blood pressure, heart rhythm, resting heart rate, weight and physical activity.

Money in the round comes from 9 unnamed investors, with the 1st sale in the round dated on March 15, according to the SEC filing. The company has not yet said how it plans to spend money raised in the round.

Earlier this month, AliveCor said it released its artificial intelligence-enabled Kardia Pro platform in the U.S. The company’s platform enables doctors to remotely monitor their patients for early signs of atrial fibrillation, a common cardiac arrhythmia.

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MassDevice.com +5 | The top 5 medtech stories for March 31, 2017

plus5-node

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

Get this in your inbox everyday by subscribing to our newsletters.

 

5. Cardiovascular Systems escapes class-action kickbacks suit

MassDevice.com news

Cardiovascular Systems (NSDQ:CSII) escaped a purported class-action lawsuit brought over allegations that it ran an off-label promotion and kickbacks scheme, but the reprieve could be short-lived because the case was dismissed without prejudice.

St. Paul, Minn.-based CSI paid $8 million to settle a federal False Claims Act suit in July 2016 that accused CSI of inducing physicians to use its products by offering free, all-expense-paid training programs “followed by explicit demands by CSI employees that attendees use CSI products on future patients,” giving away product for free, 3rd-party referral channel marketing, and “sham Speaker Bureau payments for high-prescribers and others whom CSI sought to cultivate,” according to the complaint. Read more


4. Senate bill seeks to reform Medicare’s local coverage determinations

MassDevice.com news

A bill introduced yesterday in the U.S. Senate would reform the way Medicare agencies make local coverage determinations in a bid to make the process more transparent.

The bipartisan bill, S. 794, sponsored by Sen. Johnny Isakson (R-Ga.) and co-sponsored by Sens. Thomas Carper (D-Del.), Debbie Stabenow (D-Mich.) and John Boozman (R-Ark.), would change the way Medicare Administrative Contractors make LCDs for medical devices, according to the Advanced Medical Technology Assn. Read more


3. Vascular Dynamics raises $10m for MobiusHD

MassDevice.com news

Vascular Dynamics said this week that it closed a private placement worth $10.4 million that it plans to use on the clinical program for its MobiusHD device for treating drug-resistant hypertension.

The MobiusHD implant is designed to reshape the carotid sinus to amplify the signals for baroreceptors lining the blood vessel. Implanted percutaneously, it’s designed to stimulate vasodilation. Read more


2. Incoming AdvaMed chairman Yared: We’ll take medtech tax repeal ‘in any form’

MassDevice.com news

Medtech industry lobbying group AdvaMed will maintain its focus on pursuing a full repeal of the medical device tax, no matter what form the repeal takes, according to newly appointed AdvaMed chair and CVRx prez & CEO Nadim Yared.

Yared, who was appointed to his position early last week, said the organization “is not in a position to propose where to tie in” a repeal of the tax, and that whatever form the repeal comes, the group will “probably take it.” Read more


1. Analyst: Boston Scientific could be eyeing a Neovasc buyout

MassDevice.com news

Boston Scientific is a potential acquirer for mitral valve maker Neovasc, according to JMP Securities analyst John Gillings, after agreeing to a $435 million deal for aortic valve maker Symetis that doesn’t include its Middle Peak Medical mitral valve assets.

Although the all-cash Symetis deal adds the market-ready Acurate transcatheter aortic valve implant to Boston Scientific’s structural heart portfolio, interventional cardiology president Kevin Ballinger told analysts during a conference call that the Middle Peak assets don’t fit in with its other programs. Read more

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Clearside inks clinical development deal with EyeKor

Clearside inks clinical development deal with EyeKorClearside Biomedical (NSDQ:CLSD) said today that it landed a deal with EyeKor Inc. to support its clinical trials. The companies did not disclose any financial details of the agreement.

Clearside is conducting a Phase III trial of suprachoroidally administered CLS-TA, its suspension formulation of triamcinolone acetonide, in patients with macular edema associated with non-infectious uveitis. The company is also evaluating its suprachoroidal CLS-TA, in combination with intravitreally administered Eyelea (aflibercept), in patients with macular edema associated with retinal vein occlusion.

Get the full story at our sister site, Drug Delivery Business News.

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IP firm must pony up Medtronic legal fees in dispute with Stryker

A federal judge this week ordered IP licensing firm Orthophoenix to pay $572,000, plus interest, to Medtronic to cover legal fees incurred in a suit between Orthophoenix and Stryker (NYSE:SYK) over patents formerly owned by Medtronic (NYSE:MDT).

In April 2013, Medtronic sold patents to Orthophoenix, with an agreement that the firm would “provide counsel to Medtronic” in the case of a 3rd-party claim against Medtronic, and would require Orthophoenix to “defend, indemnify and hold Medtronic harmless from any claim, damage, or liability including attorney’s fees” which related to enforcing or defending the patents.

In Oct. 2013, Orthophoenix filed a suit against Stryker claiming it infringed upon the patents it had purchased. Although Medtronic was not party to the case, Stryker sought discovery from Medtronic, according to court documents. In response, Medtronic requested that Orthophoenix indemnify the company, but Orthophoenix refused.

Orthophoenix argued that since the claim was from Orthophoenix, and not against Medtronic, it was not on the line to pay the bill. Stryker and Orthophoenix settled the case in early 2016.

This week, Delaware District Judge Leonard Stark ruled that the settlement agreement requires the Orthophoenix to cover Medtronic’s legal fees, including costs incurred from the discovery requests from Stryker.

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Cardiovascular Systems escapes class-action kickbacks suit

Cardiovascular SystemsCardiovascular Systems (NSDQ:CSII) escaped a purported class-action lawsuit brought over allegations that it ran an off-label promotion and kickbacks scheme, but the reprieve could be short-lived because the case was dismissed without prejudice.

St. Paul, Minn.-based CSI paid $8 million to settle a federal False Claims Act suit in July 2016 that accused CSI of inducing physicians to use its products by offering free, all-expense-paid training programs “followed by explicit demands by CSI employees that attendees use CSI products on future patients,” giving away product for free, 3rd-party referral channel marketing, and “sham Speaker Bureau payments for high-prescribers and others whom CSI sought to cultivate,” according to the complaint.

Plaintiff Travis Thams worked for CSI as a district sales manager from 2012 to 2013, according to the suit.

The lawsuit also accused the company of running an off-label promotion scheme to push sales of its unapproved 4 French catheter. It alleges that CSI also promoted its devices for use in areas of the body it’s not approved for, such as the coronary arteries, and for conditions such as chronic total occlusion for which it is not approved.

The class-action suit, seeking to represent shareholders who bought CSII stock between Sept. 12, 2011, and Jan. 21, 2016, alleged that the company and its management misled investors about the alleged scheme, which caused a sharp drop in the company’s share price.

This week Judge Donovan Frank of the U.S. District Court for Minnesota dismissed the suit with leave to amend, ruling that the plaintiffs failed to prove their allegations, in part because of their reliance on confidential witnesses.

“Because plaintiffs’ claim is predicated on illegal conduct, plaintiffs must plead facts that, if true, would constitute illegal conduct. Here, plaintiffs have failed to adequately plead that CSI was engaged in illegal conduct. The court therefore dismisses plaintiffs’ complaint without prejudice and grants their request for leave to amend the complaint,” Frank wrote. “Allowing shareholders to sue based on conclusory allegations that a company has engaged in widespread illegal conduct without adequately pleading facts that demonstrate illegal conduct would just allow strike suits by another name.”

The plaintiffs’ reliance on confidential witnesses failed to adequately specify their roles or how they came into their information, the judge wrote.

“Here, plaintiffs, for the most part, have failed to adequately plead the confidential witnesses’ roles or how they came into possession of the information. In particular, plaintiffs have failed to allege the job duties for the confidential witnesses. As a result, the court disregards the statements of those confidential witnesses for whom plaintiffs did not provide a description of the witnesses’ job duties,” Frank wrote. “Additionally, plaintiffs’ confidential witnesses, at times, merely relay office gossip. For example, [confidential witness 3] ‘heard’ about allegedly illegal sales practices. Similarly, vague allegations from witnesses that CSI had implemented ‘shady’ practices or that CSI was a ‘different place’ after [vice president of sales Jim] Breidenstein left are not detailed enough to be reliable. Thus, the court also disregards the confidential witnesses’ statements to the extent they are vague or based on 2nd-hand knowledge.”

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7 companies in the race to make an artificial pancreas

Over 50 years ago, scientists discovered the ability to externally control blood glucose regulation for individuals with type 1 diabetes. Since then, researchers in the field of diabetes management have dreamt of creating a closed-loop system – a combined glucose sensor, control algorithm and insulin infusion device – to effectively act as an “artificial pancreas” for people with diabetes.

Today, we can see technology approaching that apex: Major players in medtech have tossed their hats in the ring, and studies are underway worldwide as developers aim to be the 1st to provide a fully functioning artificial pancreas to people suffering from diabetes.

Medtronic is leading the pack with its MiniMed 670G, which was the 1st hybrid closed-loop system to win FDA approval, but close behind is Bigfoot Biomedical, led by homebrew artificial pancreas developer Bryan Mazlish. And there are other companies that could give Medtronic and Bigfoot a run for their money, too.

Here are 7 major medtech players looking to revolutionize diabetes treatment with their own closed-loop artificial pancreas systems.

Read the rest on Medical Design & Outsourcing>>

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MedPlast completes buy of Vention division

MedPlast Vention medtechMedPlast (Tempe, Ariz.) said today that it has closed on its acquisition of Vention’s medical device manufacturing services division.

Financial terms of the deal were not disclosed. The device manufacturing services business has locations in New Jersey, Michigan, Puerto Rico and Costa Rica.

“This acquisition is a first and important step in our strategic plan to expand our offering to customers,” MedPlast CEO Harold Faig said in a news release. “Our goal is to build on our core manufacturing and engineering capabilities to provide our customers with a comprehensive portfolio of end-to-end product solutions.”

Nordson (Westlake, Ohio) is meanwhile in the process of paying $705 million in cash to acquire Vention’s advanced technologies division, which has locations in New Hampshire, Tennessee, Ireland, Minneapolis, Massachusetts, California, Colorado and Israel.

Get the full story on our sister site, Medical Design & Outsourcing.

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Analyst: Boston Scientific could be eyeing a Neovasc buyout

Boston Scientific, NeovascBoston Scientific (NYSE:BSX) is a potential acquirer for mitral valve maker Neovasc (NSDQ:NVCN), according to JMP Securities analyst John Gillings, after agreeing to a $435 million deal for aortic valve maker Symetis that doesn’t include its Middle Peak Medical mitral valve assets.

Although the all-cash Symetis deal adds the market-ready Acurate transcatheter aortic valve implant to Boston Scientific’s structural heart portfolio, interventional cardiology president Kevin Ballinger told analysts during a conference call that the Middle Peak assets don’t fit in with its other programs.

“We currently have other investments in the mitral field,” Ballinger said. “We’re comfortable with other investment areas we have and Middle Peak won’t be part of the process here.”

Citing that comment, the 15% stake Boston already owns in Neovasc and its apparent disinterest in the piece it owns of MValve, Gillings said he wouldn’t be surprised to see the Marlborough, Mass.-based company buy up a bigger share of Neovasc – or purchase it outright.

“We believe the most likely meaning to be taken from this comment is the 15% stake it holds in NVCN,” Gillings said. “These comments, along with BSX’s strategy to be a leading player in structural heart, gives us incremental confidence that NVCN would be an ideal fit for BSX and we would not be surprised to see further investment and, potentially, an acquisition at some point in the future, perhaps tied to milestones such as clarity around the appeals process or progress toward or receipt of CE Mark.”

Marlborough, Mass.-based Boston Scientific closed the $75 million deal with Neovasc (NSDQ:NVCN) in December, acquiring that company’s advanced biological tissue business and a 15% equity stake. The company also owns a piece of another mitral valve developer, MValve.

Boston Scientific said the Acurate transcatheter aortic valve implant developed by Symetis would complement its own Lotus TAVI program, which is under a voluntary recall while Boston addresses issues with its locking mechanism. (The Lotus platform is expected to return to market in the 4th quarter.) Symetis won CE Mark approval for the Acurate Neo device in 2014 and is running a clinical trial for the next-generation Acurate Neo/AS TAVI ahead of a bid for EU approval.

Boston Scientific said it expects the deal, slated to close during the 2nd quarter, to be “immaterial” to adjusted earnings per share this year but “slightly accretive” in 2018 and “increasingly accretive” after that.

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RenovoRx wins label expansion for RenovoCath device

RenovoRx wins label expansion for RenovoCath deviceRenovoRx said yesterday that it won label expansion for the RenovoCath dual-balloon infusion catheter to include the delivery of chemotherapeutics. The device isolates segments of the peripheral vasculature, allowing doctors to deliver therapeutics in a more targeted fashion, according to the Los Altos, Calif.-based company.

“This additional FDA indication marks yet another milestone for RenovoRx as we continue to work towards making our technology available to physicians to treat difficult diseases,” CEO Shaun Bagai said in prepared remarks.

Get the full story at our sister site, Drug Delivery Business News.

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Researchers develop polymer capsules for targeted drug delivery

Researchers develop polymer capsules for targeted drug deliveryResearchers at the University of Alabama at Birmingham have developed cancer-fighting polymer capsules that they suggest could be used for targeted drug delivery of chemotherapeutics. The team’s work was published in ACS Nano.

The multi-layer capsules feature good imaging contrast, as well as efficient encapsulation of doxorubicin, according to the researchers. The vessels are triggered by low- and high-power doses of ultrasound to release their cargo.

Get the full story at our sister site, Drug Delivery Business News.

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Senate bill seeks to reform Medicare’s local coverage determinations

Capitol HillA bill introduced yesterday in the U.S. Senate would reform the way Medicare agencies make local coverage determinations in a bid to make the process more transparent.

The bipartisan bill, S. 794, sponsored by Sen. Johnny Isakson (R-Ga.) and co-sponsored by Sens. Thomas Carper (D-Del.), Debbie Stabenow (D-Mich.) and John Boozman (R-Ark.), would change the way Medicare Administrative Contractors make LCDs for medical devices, according to the Advanced Medical Technology Assn.

It would require MAC meetings to be open to the public and on the record, and mandate disclosure for the reasoning behind a local coverage determination including the evidence backing the decision. The measure would also create an appeals process and bar MACs from adopting LCDs made in other jurisdictions without an independent evaluation, according to AdvaMed.

“Unfortunately, the Local Coverage Determination (LCD) process MACs use is flawed, lacks transparency and does not provide meaningful opportunity for stakeholder input or appeals. As a result, American patients are at risk of being denied access to technologies and services they need,” AdvaMed president & CEO Scott Whitaker said in prepared remarks. “AdvaMed commends Sens. Isakson, Carper, Stabenow and Boozman for their leadership on this issue. This bill builds on provisions to improve the LCD process in the recently passed 21st. Century Cures Act and will foster greater transparency, consistency and objectivity in the process, which will ultimately benefit Medicare beneficiaries. We look forward to working with members of Congress, CMS and other key stakeholders to advance this legislation.”

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Vascular Dynamics raises $10m for MobiusHD

Vascular Dynamics MobiusHDVascular Dynamics said this week that it closed a private placement worth $10.4 million that it plans to use on the clinical program for its MobiusHD device for treating drug-resistant hypertension.

The MobiusHD implant is designed to reshape the carotid sinus to amplify the signals for baroreceptors lining the blood vessel. Implanted percutaneously, it’s designed to stimulate vasodilation.

All of Vascular Dynamics’ major backers participated the round of promissory notes convertible to Series C stock, the company said.

“We continue to be gratified in the confidence our current investor group shows in Vascular Dynamics. The MobiusHD device has provided encouraging data in our European and American trials, and the response that the regulatory agencies have given the company to date reflect what we have believed all along, which is that the MobiusHD system has the potential to save millions of lives threatened by a condition that has no symptoms, but results in millions of deaths each year,” president & CEO Robert Stern said in prepared remarks. “This financing is continued demonstration of that confidence in our technology and a tribute to those who have worked so hard toward bringing it to fruition.”

Vascular Dynamics won CE Mark approval in the European Union for Mobius HD in January 2016. Proceeds from the private placement are earmarked for an ongoing investigational device exemption study in the U.S., ahead of a bid for pre-market approval from the FDA. The federal safety watchdog has the Mountain View, Calif.-based company on the expedited access pathway for its PMA.

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Johnson & Johnson’s tender offer for Actelion snares 78% stake

Johnson & Johnson's tender offer for Actelion snares 78% stakeJohnson & Johnson (NYSE:JNJ) said today that it controls nearly 78% of voting rights in its $30 billion acquisition of Swiss biotech firm Actelion (VTX:ATLN). Janssen, J&J’s Swiss subsidiary, declared the tender offer successful.

The company added that based on regulatory approval proceedings, the offer is expected to settle in the 2nd quarter of this year.

Get the full story at our sister site, Drug Delivery Business News.

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FDA in India – championing a culture of quality

Mary Lou ValdezBy: Mary Lou Valdez

One of FDA’s most strategic outposts is in India, the seventh largest supplier of food and second largest supplier of pharmaceuticals and biologics to the United States. The agency’s office, located in the capital, New Delhi, works to ensure the safety and security of food and the safety and efficacy of medical products exported from India to the U.S.

To achieve that goal, the India Office, directed by Mathew Thomas, conducts inspections of Indian medical products and foods facilities that export to the U.S. The office also assists and trains regulators, industry, and other stakeholders in developing and maintaining the quality, safety, and effectiveness of the FDA-regulated products they export.

It’s important for the office to consult regulatory authorities in India to build confidence in each other and to develop quality standards that both countries can trust.

I had the privilege of joining Director Thomas last month for meetings with our regulatory counterparts – the Indian Export Inspection Council (EIC), the Food Safety Standards Agency of India (FSSAI), the Drugs Controller General of India (DCGI), and the Joint Secretary of the Ministry of Health and Family Welfare.

Despite the diversity of these agencies’ mandates and priorities, a common theme coming out of these meetings was the recognition of the mutual benefits we realize by working together to enhance the effectiveness of our regulatory systems and to advance risk-based and science-based approaches to food and medical product regulation.

Along with other FDA experts, I also participated in a Global Food Safety Partnership (GFSP) Governing Council meeting and the Indian Pharmaceutical Alliance (IPA) Second Forum, titled “Towards Excellence in Quality.” Hosted by the Word Bank, the GFSP is a public private partnership, established in 2012, which brings together governments, industry, multilateral organizations, and other stakeholders in support of stronger food safety systems. Since its founding, the GFSP has worked with China, Indonesia, and Vietnam. During my visit, we had initial GFSP meetings with Indian regulators, to explore potential synergies as they look to bolster their food safety systems and maximize their investments. FDA’s India Office is well-positioned to help the Partnership and India explore how best to meet these goals.

The IPA Forum brings together CEOs of pharmaceutical firms, manufacturers, regulators, and other national and global stakeholders who have a role in shaping India’s complex and diverse manufacturing environment to produce safe, effective, high-quality medical products.

Over the past decade, the Indian pharmaceutical market has grown by nearly 14 percent and continues to experience massive growth. However, in order to fully realize the nation’s potential as an important player in the global pharmaceutical industry, India’s regulatory infrastructure must keep pace to ensure that global quality and safety demands are met. Quality issues are an ongoing challenge for the Indian pharmaceutical industry. Of 42 warning letters issued by FDA’s Office of Manufacturing Quality last year, nine went to Indian facilities. The IPA is working to communicate to its diverse members why quality matters and how to achieve it. Thus, the general theme of its Second Forum “Towards Excellence in Quality,” was an incredibly relevant topic if the global market for FDA-regulated products is to be strong and secure.

No one wants resources wasted on ineffectual development and weak processing or manufacturing systems that could actually impede product success. We all want greater competition, increased options for consumers and patients, and more affordable alternatives to comparable products.

Participants agreed that achieving quality requires regulators and industry alike to champion and advance a quality culture throughout the product life-cycle, by effectively employing the use of data and science and requiring greater transparency.

While I was in India, it was really gratifying to witness the high-esteem and trust Indian regulators and industry have for FDA, and our India Office. In turn, whether it is through their response to inspectional observations, their participation in trainings and seminars or their readiness to share strategic information, we see India committing to quality and compliance. Indian regulators and industry both recognize that a quality culture is imperative if India is to increase productivity, reduce compliance risk, lessen rework, and minimize supply interruptions that result in lost revenue and increased risks to public health.

This greater emphasis on quality will also allow India to participate more fully in existing global venues such as the International Council for Harmonisation (ICH) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S) – which will enable stronger collaboration and synergies among regulators.

Quality is good for economic development, the market, and most importantly, patients and consumers everywhere. FDA’s Office in New Delhi looks forward to continued collaboration with our Indian regulatory colleagues to champion a culture of quality.

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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dijous, 30 de març del 2017

InVivo enlists 1st Canadian site in cervical spinal scaffold study

InVivo Therapeutics

InVivo Therapeutics (NSDQ:NVIV) said today that the Toronto Western Hospital will be the 1st Canadian site in the newly-launched study of its neuro-spinal scaffold in patients with acute, complete AIS A cervical spinal cord injuries.

The neuro-spinal scaffold is designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting, InVivo said.

Dr. Michael Fehlings will serve as principal investigator at the site, the Cambridge, Mass.-based comapny said. Fehlings also serves as a principal investigator at the hospital for InVivo’s Inspire study of the neuro-spinal scaffold for treating patients with acute thoracic spinal cord injuries.

“Our centre remains enthusiastic about addressing the unmet need in cervical spinal cord injuries and being part of InVivo’s pioneering efforts in this exciting and promising field,” Dr. Fehlings said in a prepared statement.

“We are thrilled to launch our cervical study in Canada with one of the most prominent leaders in spinal cord injury research. We admire Dr. Fehlings’ and Toronto Western Hospital’s dedication to helping us evaluate our technology through both the cervical study and the INSPIRE study. We look forward to continuing to work with Dr. Fehlings and Toronto Western Hospital,” CEO Mark Perrin said in a press release.

Earlier this week, InVivo announced that a patient enrolled in January in its Inspire study has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury. This is the 7th patient from the 11-patient group to have an AIS grade improvement with at least 1-month of follow-up.

2 other patients have not yet had their 1-month follow-up visit, according to the company. InVivo added that the AIS conversation rate observed in its Inspire study is “considerably higher” than the rates found in a range of spinal cord injury natural history databases.

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AngioDynamics shares rise on Q3 EPS beat

AngioDynamics

Shares in AngioDynamics (NSDQ:ANGO) rose today after the medical device maker topped earnings per share expectations on Wall Street with its 3rd quarter earnings.

The Albany, N.Y.-based company posted profits of $2.9 million, or 8¢ per share, on sales of $85.6 million for the 3 months ended Feb. 28, for massive bottom-line growth of 386% while sales shrunk 2.1% compared with the same period last year.

After adjusting to exclude 1-time items, earnings per share were 19¢, well above the 15¢ consensus on The Street, where analysts were expecting to see sales of $88.3 million, which the company narrowly missed.

“The quarter demonstrates continued execution on our core imperatives to improve our operational efficiency, strengthen our balance sheet and move forward on initiatives that will enable us to deliver sustainable top line revenue growth. We have already taken several positive steps to improve our operational efficiency and simplify our supply chain, and in February we made the decision to consolidate operations in Denmead, U.K. and Manchester, Ga. into our New York facilities.As the quarter ended, we obtained CE Mark certification for the Solero Microwave Tissue Ablation System. With an initial launch in Europe in April, we await FDA approval in the U.S. which we believe will fortify our global position in the innovative ablation market. To support our long-term performance, we will remain focused on delivering high value products within growing markets by better leveraging our renewed R&D process and our existing portfolio of high value offerings like BioFlo and NanoKnife,” prez & CEO Jim Clemmer said in a press release.

The company revised its financial guidance for its full fiscal year 2017, lowering its revenue expectations while raising its adjusted EPS guidance.

For the full year, the company expects to bring in between $352 million and $355 million, down from $355 million to $360 million, with earnings per share between 68¢ and 70¢, up from previous guidance of 65¢ and 67¢.

Shares closed up 1.7% at $17.58 today.

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FDA clears Bodycad’s personalized unicompartmental knee system

Bodycad

Canadian orthopedic developer Bodycad said today it won FDA 510(k) clearance for its Bodycad unicompartmental knee system and launched the device in the US.

The company said that the clearance makes it the 1st Canadian company to win FDA clearance for a joint reconstruction implant system.

“The personalized restoration is created only after proper acquisition of data from the patient on an individualized level. The benefit of personalized restoration is the possibility of a better fit to the individual, less trauma to the soft tissue, and potentially a faster recovery overall,” Dr. Etienne Belzile of Laval University said in a prepared statement.

Bodycad’s unicompartmental knee systems are personalized through the use of 3D renderings of medical images of the patient’s anatomy, the company said. The system uses proprietary imaging algorithms to create a precise 3D image of the patient’s knee and is delivered as part of a “procedure in a box,” Bodycad said.

“Our proprietary software is based on 20 years of research in anthropometric data and is the first CAD/CAM software specifically developed for the personalization of orthopaedic implant and instrument design. I am delighted to have FDA clearance to bring this important technological advancement to market. Our goal is to transform the way surgeons, patients and insurers think about the potential of mass customization to optimize patient care,” founder & CEO Jean Robichaud said in a press release.

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Study: Why even targeted lung cancer therapies eventually fail

Study: Why even targeted lung cancer therapies eventually failEven when patients are treated with targeted cancer therapies, many lung cancer patients suffer a recurrence. Researchers at Cold Spring Harbor Laboratory wanted to uncover how some cancers escape the power of targeted treatment. Their work was published in the journal eLife this week.

The team of scientists, lead by Raffaella Sordella, found that a tiny subset of cells in or around a cancerous tumor can change over time and become the seeds of a killer relapse.

Get the full story at our sister site, Drug Delivery Business News.

 

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Why regional reimbursement strategies could be right for medtech

The medtech space is facing increasing challenges, particularly in the reimbursement space. Although the process is difficult, device makers may find that regional reimbursement strategies better suit their immediate needs to get products to market, according to Seth J. Goldenberg, PhD, director of product development strategy at NAMSA.

[Image by marsroverdriver via Flickr, using Creative Commons license.]

Device makers are under increasing pressure to ensure that their devices are not simply achieving regulatory approval, but have a plan for payments. And these days, Goldenberg said, CMS is not always the best route. “Going for a national coverage can seem like the best option,” Goldenberg said. “The problem with CMS is that if you don’t get what you want, it’s a national decision.”

 

Such blanket decisions are oppositional to the nature of medical technology today. “Medical devices are too complex, too dynamic, and too customized.”

Find out more at our sister site, Medical Design & Outsourcing

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MassDevice.com +5 | The top 5 medtech stories for March 30, 2017

plus5-node

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

Get this in your inbox everyday by subscribing to our newsletters.

 

5. ADM Cleveland: Here are some top medtech manufacturing highlights

MassDevice.com news

The inaugural Advanced Design and Manufacturing is showcasing some of the medical device industry’s top design and manufacturing technology this week at the Huntington Convention Center in Cleveland, Ohio.

From manufacturing depression treating machines to dry ice cleaning machines, here are 8 exhibitors you should check out at ADM Cleveland. Read more


4. Integer CEO Hook steps down

MassDevice.com news

Integer Holdings said this week that current CEO Thomas Hook has stepped down as the company’s president and CEO, effective immediately, with Joseph Dziedzic taking over as interim prez & CEO.

Hook will stay on the Frisco, Texas-based company’s board until the company’s 2017 annual meeting of stockholders, but will not seek re-election. Read more


3. Not so fast: Utah’s Hatch thinks medtech levy repeal could still be part of tax reform

MassDevice.com news

Despite House Republicans’ insistence that any taxes associated with Obamacare – including the medical device tax – won’t be part of the negotiations over tax reform, Sen. Orrin Hatch (R-Utah) that the overall tax package could include the repeal of taxes put in place by the Affordable Care Act.

The 2.3% excise tax on U.S. medical device sales was enacted along with the ACA in 2010 and went into effect in 2013. A 2-year moratorium put in place in 2015 is slated to expire at the end of this year; proponents of repealing the tax were hopeful that the ACA repeal-and-replace legislation that failed last week would put a permanent nail in the levy’s coffin. Read more


2. ConvaTec expands Unomedical infusion set biz for Medtronic

MassDevice.com news

ConvaTec said today that it’s expanding its Unomedical infusion set business to keep pace with the diabetes segment at Medtronic.

The British wound care and colostomy supplies maker said the expansion of Unomedical’s production capacity is part of a decades-long partnership with Fridley, Minn.-based Medtronic. Unomedical makes disposable infusion sets for a range of Medtronic MiniMed insulin pumps, including the QuickSet, Silhouette, Sure-T and Mio sets. Read more


1. Boston Scientific puts up $435m for Symetis just ahead of IPO

MassDevice.com news

Boston Scientific is putting up $435 million in cash for Symetis and its line of minimally invasive replacement heart valves, the companies said today.

The buyout halts the 2nd run at an initial public offering by Symetis, which launched the IPO March 20 in a bid to raise up to $66 million (€61.5 million) on the Euronext exchange in Paris. The Ecublens, Switzerland-based company, which acquired Middle Peak Medical and its transcatheter mitral valve implant just last month, spiked its 1st, $96 million IPO attempt in September 2015. Symetis employs about 300 workers worldwide. Read more

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Merck, Avillion ink development deal for nanobody psoriasis treatment

Merck, Avillion ink development deal for nanobody psoriasis treatmentMerck (NYSE:MRK) and Avillion inked a clinical co-development deal today for Merck’s anti IL-17 A/F Nanobody therapy for plaque psoriasis. The financial terms of the deal were not disclosed.

The investigational treatment underwent Phase I development and the group plans to initiate Phase II trials this year. According to the terms of the agreement, Avillion is responsible for bringing the nanobody treatment from Phase II to Phase III and financing the clinical program through to regulatory submission.

Get the full story at our sister site, Drug Delivery Business News.

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Abiomed doubles Danvers footprint

MA Governor Charlie Baker, Abiomed CEO Mike Minogue and patient survivors cut the ribbon on the newly expanded Abiomed Global HQ and Heart Recovery Institute for clinical education in Danvers, MA.Abiomed (NSDQ:ABMD) today opened its expanded headquarters in Danvers, Mass., which more than doubles its footprint in the Bay State.

Gov. Charlie Baker helped Abiomed CEO Mike Minogue and patient survivors to cut the ribbon on the $40 million, 160,000-square-foot HQ north of Boston.

Abiomed makes the Impella line of percutaneous heart pumps, which are designed to provide cardiac support to heart failure patients during PCI procedures. The expansion adds new R&D and manufacturing facilities and a clinical training facility called the Heart Recovery Institute.

“Today we recognize 35 years of dedication and hard work by all the people who made this possible — from employees, to customers, to patients, to investors,” Minogue said in prepared remarks. “We celebrate our Patients First culture and this investment in our future. We are proud to add new clinical, engineering and manufacturing jobs in Massachusetts because it will ensure faster innovation, quality, and compliance. Our mission is to help recover hearts; now we have the manufacturing infrastructure to support enough patients to fill Fenway Park each year.”

“With Massachusetts-based companies like Abiomed helping to lead the way, the Commonwealth continues to be a global leader in health care, innovation and technology,” Baker added. “I am pleased to continue to witness the growth of a company that has invested in Massachusetts for more than 35 years and we look forward to continuing to work together to create jobs and develop the state’s innovation economy.”

Abiomed said it’s added more than 150 engineering and manufacturing jobs to the site since it broke ground in June 2015, taking its headcount to more than 400 employees in Massachusetts. The company employs nearly 1,000 people globally, it said, noting expansions also under way in Berlin and Aachen, Germany, and Tokyo.

Leerink Partners analysts said Abiomed is on track to meet its $1 billion revenue goal by fiscal 2021, from its indications for high-risk PCI and cardiogenic shock (the company is pursuing other indications.

“We believe this is easily doable given: (1) A still highly under-penetrated market opportunity, just 7% penetrated of the total current addressable market of 221k; and, (2) Impella is the only FDA percutaneous heart pump deemed ‘safe and effective’ for treatment of cardiogenic shock and high-risk PCI,” analysts Danielle Antalffy and Rebecca Wong wrote today in a noto to investors. “Ultimately, we believe Impella is well-positioned to become [the] standard of care longer-term as physicians become increasingly aware of the benefits of Impella on a) mortality and b) cost-efficacy – not to mention patient quality of life – and as experience with the system grows.”

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Biotronik touts doctors’ survey responses for Magmaris drug-eluting scaffold

Biotronik touts doctors' survey responses for Magmaris drug-eluting scaffoldBiotronik touted data today from its Magnesium 1,000 program, which provided doctors with an early post-market opportunity to evaluate the company’s new resorbable Magmaris magnesium scaffold. More than 98% of physicians reported that the scaffolds successfully deployed, according to the data, and that it performed well compared to the leading polymeric scaffold, Biotronik said.

The program began in June last year and included more than 400 physicians in 237 hospitals across 32 countries. Biotronik asked the participating physicians to rate their personal experiences of acute performance with Magmaris and to compare their experiences with the leading polymeric scaffold for each case.

Get the full story at our sister site, Drug Delivery Business News.

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Medtronic launches Arctic Front cryoablation PVI study

Medtronic

Medtronic (NYSE:MDT) said today it enrolled the 1st patient in the Stop Persistent AF clinical trial of its Arctic Front Advance cardiac cryoablation catheter.

The 225-patient, 12-month trial aims to explore the effectiveness and safety of pulmonary vein isolation-only treatments for patients with persistent atrial fibrillation using the Arctic Front Advance cryoablation catheter, the Fridley, Minn.-based company said.

The 1st patient in the trial was treated by Dr. John Harding at Penn.’s Doylestown Hospital, the company said.

“Gaining meaningful data from this trial will help further clinicians’ understanding of possible treatment options for patients with persistent AF. As AF progresses and episodes become more constant, patients’ quality of life diminishes while their risk of AF-related health effects, such as heart failure and stroke, increases. This trial could help us advance care for this hard-to-treat population,” co-principal investigator Dr. Hugh Calkins of Baltimore’s Johns Hopkins Hospital said in a prepared statement.

Medtronic said that recently updated guidelines from the European Society of Cardiology supported cryoablation therapy for treating AF, and supported PVI as an effective and preferred treatment for select patients with AF.

“According to a study in JAMA, the number of patients with AF is expected to double in the next couple of decades and we want to ensure that physicians are equipped with the most innovative approaches and treatments. We hope this study leads to greater insights that can improve care for patients with persistent AF,” AF solutions biz GM Colleen Fowler said in a press release.

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Incoming AdvaMed chairman Yared: We’ll take medtech tax repeal ‘in any form’

Medical device tax

Medtech industry lobbying group AdvaMed will maintain its focus on pursuing a full repeal of the medical device tax, no matter what form the repeal takes, according to newly appointed AdvaMed chair and CVRx prez & CEO Nadim Yared.

Yared, who was appointed to his position early last week, said the organization “is not in a position to propose where to tie in” a repeal of the tax, and that whatever form the repeal comes, the group will “probably take it.”

“In general, the guiding principal we are walking with right now is to ensure that we have a medical device tax repeal, no matter what form. Whether it’s in the healthcare reform bill, the tax reform bill or a stand alone bill, or any other form the house and senate will propose to us, we will consider it seriously and probably take it. We are not in a position to propose where to tie in, right now, the medical device excise tax repeal bill,” Yared said in a conference today.

The reauthorization of user fees is next on the agenda for the group, Yared said, with negotiations already underway, well ahead of the Sept. 30 deadline.

“Regarding the reauthorization of user fees, the industry and the FDA negotiated a very good deal for MDUFA 4, one that benefits patients, the agency and innovation. We remain committed to the medical device user fee agreement as negotiated, which represents a substantial investment of fees which will help improve the review process and get new medical technologies to patients in need. We just had hearings in both the House and Senate on MDUFA, and Congress has planned to wrap up their work long before the Sept. 30 deadline for reauthorization. We urge congress to move quickly on this reauthorization so that the progress at the FDA can continue uninterrupted,” Yared said.

Yared also said they would continue to work with the FDA as they continue to implement the 21st century cures act.

While the group supports expanding the resources of the FDA and other agencies, AdvaMed has “no comment” on the incoming budget from the Trump Administration and its proposed cuts to the NIH and other organizations Yared said.

“We don’t claim that we have the answers yet, we have not had the time to analyze all of the proposals. I wish we had received a more detailed schedule of the budget proposals,” Yared said. “We are for increasing the resources in the government agencies, particularly the FDA, to help us deliver the innovative products that we need to deliver. That will be our focus. I’m sorry, we cannot comment on the budget since we have not yet seen the details and do not know what the house or senate will counter with.”

AdvaMed split from other healthcare groups earlier this month by throwing its support behind the GOP-backed Trumpcare bill solely to see the medical device tax repealed. The legislation was pulled last week after it failed to gain enough support to pass the GOP-controlled house.

The 2.3% excise tax on U.S. medical device sales was enacted along with the Affordable Care Act in 2010 and went into effect in 2013. A 2-year moratorium put in place in 2015 is slated to expire at the end of this year; proponents of repealing the tax were hopeful that the repeal-and-replace legislation that failed last week would put a permanent nail in the levy’s coffin.

The group may still have a chance to see the tax repealed this year, however. Despite House Republicans’ insistence that any taxes associated with Obamacare – including the medical device tax – won’t be part of the negotiations over tax reform, Sen. Orrin Hatch (R-Utah) said that the overall tax package could include the repeal of taxes put in place by the Affordable Care Act.

Hatch, chairman of the Senate Finance Committee, put the Obamacare tax repeal back on the table – either as part of the tax reform negotiations or a revised healthcare reform bid.

“Either, as far as I’m concerned,” Hatch said. “Any way we can get rid of those, I think it’d be a good thing,”

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Samsung Biologics slides on South Korean regulatory probe

Samsung BiologicsNews that Samsung Biologics is facing a probe by South Korean regulators over its valuation ahead of an initial public offering last year sent its share price down this week in Seoul.

South Korea’s Financial Supervisory Service is running a special audit of the drugs contract manufacturer, prompted by a Korean Institute of Certified Public Accountants review that found “unclear parts” in audits run before the IPO.

Get the full story on our sister site, Drug Delivery Business News.

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SteadyMed reels in losses with Q4 earnings

SteadyMed reels in losses with Q4 earningsShares in SteadyMed (NSDQ:STDY) rose yesterday after the pharmaceutical company reported its 4th quarter results.

The San Ramon, Calif.-based company posted losses of -$2.4 million, or -12¢ per share, on sales of $400,000 for the 3 months ended Dec. 31, for bottom-line growth of 63.1% on sales loss of -25.6% compared with the same period last year.

“2016 was a year of important progress for SteadyMed, which saw our company significantly advance the development of its lead product candidate, Trevyent for the treatment of PAH. These are exciting times for SteadyMed as we look forward to learning of our IPR ruling in April and submit our NDA for Trevyent to the FDA at the end of the 2nd quarter,” president & CEO Jonathan Rigby said in prepared remarks.

Get the full story at our sister site, Drug Delivery Business News.

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Capsugel expands into late-stage inhalation delivery

Capsugel expands into late-stage inhalation deliveryCapsugel said today that it expanded its late-stage inhalation formulation capabilities to move dry powder inhalation concepts through late-stage clinical trial and into commercial production. The company installed a new Harro Hofliger Modu-C MS encapsulation unit at its Oregon-based facility.

The machinery features specialized drum-dosing tech for use in dry powder inhalation development projects with spray-dry processing, Capsugel said.

Get the full story at our sister site, Drug Delivery Business News.

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ConvaTec expands Unomedical infusion set biz for Medtronic

MiniMed Quick-setConvaTec (LON:CTEC) said today that it’s expanding its Unomedical infusion set business to keep pace with the diabetes segment at Medtronic (NYSE:MDT).

The British wound care and colostomy supplies maker said the expansion of Unomedical’s production capacity is part of a decades-long partnership with Fridley, Minn.-based Medtronic. Unomedical makes disposable infusion sets for a range of Medtronic MiniMed insulin pumps, including the QuickSet, Silhouette, Sure-T and Mio sets.

“We are excited to expand our long-standing partnership with Medtronic, sharing advanced technologies and complementary competencies to ensure that we can meet the needs of the increasing number of people with diabetes who are depending on insulin pump therapy,” infusion devices president John Lindskog said in prepared remarks. “Together, we have a great foundation for offering the best solutions for people with diabetes, giving them more control and freedom in their lives.”

“We have a trusted partner in Unomedical with significant manufacturing know-how and a long track record of delivering reliable, high quality consumable components as we continue to expand our insulin pump business around the world,” added Medtronic vice president Bogdan Madzar. “Together, we are advancing innovations that expand the options for people using insulin pumps as we seek to both improve outcomes and satisfy lifestyle needs so that people with diabetes can enjoy greater freedom and better health.”

ConvaTec’s private equity owners yesterday drummed up $1.21 billion by selling off a 19% stake in the British medical device maker.

PE shops Nordic Capital and Avista sold 375 million shares at £2.60 apiece in the over-subscribed offering, after raising the float from 300 million shares, according to bookrunner UBS.

Other investors sold another 389 million shares, or about 20% of ConvaTec, to Novo Nordisk (NYSE:NVO) for about $1.25 billion (£1.01 billion). Novo CEO Kasim Kutay is slated to join the Reading, U.K.-based company’s board, the Danish diabetes giant said.

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Aura Biosciences wins fast track designation for light-activated nanoparticle therapy

Aura Biosciences wins fast track designation for light-activated nanoparticle therapyAura Biosciences said today that it enrolled and dosed the 1st patient in the Phase Ib trial of its light-activated AU-011 viral nanoparticle conjugate therapy for the treatment of ocular melanoma. The company also said that the FDA granted fast track designation to its targeted treatment, which will give priority review for the company’s New Drug Application.

Administered through the eye, the company’s AU-011 therapy is composed of viral nanoparticle conjugates that selectively bind to cancer cells in the eye. The treatment is activated using an ophthalmic laser, at which point it specifically destroys tumor cells’ membranes while avoiding healthy eye structures, Aura reported.

Get the full story at our sister site, Drug Delivery Business News.

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Not so fast: Utah’s Hatch thinks medtech levy repeal could be part of tax reform

Capitol HillDespite House Republicans’ insistence that any taxes associated with Obamacare – including the medical device tax – won’t be part of the negotiations over tax reform, Sen. Orrin Hatch (R-Utah) that the overall tax package could include the repeal of taxes put in place by the Affordable Care Act.

The 2.3% excise tax on U.S. medical device sales was enacted along with the ACA in 2010 and went into effect in 2013. A 2-year moratorium put in place in 2015 is slated to expire at the end of this year; proponents of repealing the tax were hopeful that the ACA repeal-and-replace legislation that failed last week would put a permanent nail in the levy’s coffin.

But the Republican healthcare reform plan went down in flames last week before it could come to a vote, with Rep. Kevin Brady (R-Texas), chairman of the House Ways & Means Committee, taking Obamacare taxes off the table for the tax reform push.

“We never envisioned bringing Obamacare taxes into that [tax reform] effort and I still don’t,” Brady said, noting that the ACA taxes “go away when we repeal and replace. And so regrettably, they stay in place.”

Hatch, chairman of the Senate Finance Committee, yesterday put the Obamacare tax repeal back on the table – either as part of the tax reform negotiations or a revised healthcare reform bid.

“Either, as far as I’m concerned,” Hatch said. “Any way we can get rid of those, I think it’d be a good thing.”

Material from Reuters was used in this report.

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Acorda plans NDA for inhaled Parkinson’s drug after touting long-term safety data

Acorda plans NDA for inhaled Parkinson's drug after touting long-term safety dataAcorda Therapeutics (NSDQ:ACOR) touted data from 2 ongoing, long-term safety studies of its inhaled Parkinson’s therapy. The trials showed no difference in pulmonary function between the group receiving CVT-301, the inhaled formulation of Parkinson’s drug levodopa, and the control group.

The investigational drug is being studied as a therapy for people with Parkinson’s disease experiencing “off” periods, or a re-emergence of symptoms. The Ardsley, N.Y.-based company said the 12-month safety results are consistent with data from Phase IIb and III clinical evaluations.

Get the full story at our sister site, Drug Delivery Business News.

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ADM Cleveland: Here are some top medtech manufacturing highlights

The inaugural Advanced Design and Manufacturing is showcasing some of the medical device industry’s top design and manufacturing technology this week at the Huntington Convention Center in Cleveland, Ohio.

From manufacturing depression treating machines to dry ice cleaning machines, here are 8 exhibitors you should check out at ADM Cleveland.

Next >>

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Boston Scientific puts up $435m for Symetis just ahead of IPO

Boston Scientific acquires SymetisBoston Scientific (NYSE:BSX) is putting up $435 million in cash for Symetis and its line of minimally invasive replacement heart valves, the companies said today.

The buyout halts the 2nd run at an initial public offering by Symetis, which launched the IPO March 20 in a bid to raise up to $66 million (€61.5 million) on the Euronext exchange in Paris. The Ecublens, Switzerland-based company, which acquired Middle Peak Medical and its transcatheter mitral valve implant just last month, spiked its 1st, $96 million IPO attempt in September 2015. Symetis employs about 300 workers worldwide.

Boston Scientific said the Acurate transcatheter aortic valve implant developed by Symetis would complement its own Lotus TAVI program, which is under a voluntary recall while Boston addresses issues with its locking mechanism. (The Lotus platform is expected to return to market in the 4th quarter.) Symetis won CE Mark approval for the Acurate Neo device in 2014 and is running a clinical trial for the next-generation Acurate Neo/AS TAVI ahead of a bid for EU approval.

“The steps we are taking reflect our commitment to being a leader in TAVI and structural heart technologies now and over the long-term, as we broaden our portfolio and pipeline to address the needs of our global health care providers and their patients,” global chief medical officer Dr. Ian Meredith said in prepared remarks. “The Acurate family of valve products is strongly complementary to our cornerstone Lotus valve platform, and this compelling combination of technologies will allow us to provide interventional cardiologists and cardiac surgeons with multiple TAVI offerings for varying patient pathologies and anatomy.”

“Over the past years, Symetis matured into a TAVI player with fast growth and a solid clinical reputation. The IPO that we were pursuing until yesterday on Euronext Paris was meant to give Symetis the means to commercially expand beyond Europe and to further grow into the exciting field of structural heart. We are very pleased by the positive response we received from the investment community, which we want to thank for the interest it has shown in Symetis. However, as of today, the company is taking another path by joining Boston Scientific. The global scale and strong legacy of Boston Scientific in interventional cardiology will further propel Symetis’ clinical excellence. As a result, we can expect more patients to be better treated for valvular heart disease globally. Moving forward, this means an exciting development path for the Symetis team,” added Symetis CEO Jacques Essinger.

Boston Scientific said it expects the deal, slated to close during the 2nd quarter, to be “immaterial” to adjusted earnings per share this year but “slightly accretive” in 2018 and “increasingly accretive” after that.

($1 = €0.93)

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FDA launches Experimental Learning Program

Emergo GroupBy Stewart Eisenhart, Emergo Group

The US Food and Drug Administration is rolling out a new program whereby regulatory staff learn about new and innovative medical device technologies from industry to enhance premarket reviews and other regulatory processes.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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dimecres, 29 de març del 2017

Siemens Medical wins $4B DoD radiology supply contract

Siemens Healthineers

Siemens (NYSE:SI) Healthineers healthcare division won a maximum $4 billion contract with the US Department of Defense, according to a DoD release.

The 5-year deal is a firm-fixed-price, indefinite delivery and indefinite quantity contract for radiology systems, as well as accessories and training for such devices, according to the release.

Through the contract, Siemens will provide radiology equipment and services to the Army, Navy, Air Force, Marine Corps and other federal civilian agencies.

Siemens won out over 27 different applications, according to the DoD. The contract has a completion date of March 27, 2022.

Last month, Siemens was reported to be mulling the idea of a US initial public offering for its Healthineers healthcare business, according to a German newspaper which spoke to its chief exec.

The healthcare business, which Siemens rebranded last year to worldwide scorn, is the company’s most profitable unit with an estimated enterprise value of roughly €36 billion to €37 billion ($39 billion to $40 billion).

While the possibility of a US IPO is being considered, it’s not certain yet, CEO Joe Kaeser told Euro am Sonntag.

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